Prescription drug · ANDA
Dapsone NDC 82804-989
Dapsone 100 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-989-00 | 82804098900 | 100 TABLET in 1 BOTTLE (82804-989-00)Marketed from May 21, 2024 | |
| 82804-989-11 | 82804098911 | 1000 TABLET in 1 BOTTLE (82804-989-11)Marketed from May 21, 2024 | |
| 82804-989-30 | 82804098930 | 30 TABLET in 1 BOTTLE (82804-989-30)Marketed from May 21, 2024 | |
| 82804-989-55 | 82804098955 | 500 TABLET in 1 BOTTLE (82804-989-55)Marketed from May 21, 2024 | |
| 82804-989-60 | 82804098960 | 60 TABLET in 1 BOTTLE (82804-989-60)Marketed from May 21, 2024 | |
| 82804-989-64 | 82804098964 | 240 TABLET in 1 BOTTLE (82804-989-64)Marketed from May 21, 2024 | |
| 82804-989-72 | 82804098972 | 120 TABLET in 1 BOTTLE (82804-989-72)Marketed from May 21, 2024 | |
| 82804-989-78 | 82804098978 | 180 TABLET in 1 BOTTLE (82804-989-78)Marketed from May 21, 2024 | |
| 82804-989-90 | 82804098990 | 90 TABLET in 1 BOTTLE (82804-989-90)Marketed from May 21, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Dapsone
- Generic name (nonproprietary)
- dapsone
- Active ingredients
- Dapsone — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 086842
- Marketing start
- Listing expires
- Other FDA classes
- Sulfones (Chemical structure)
- Identifiers
- Product ID 82804-989_9cfe5fe7-abc7-4f48-a597-1b1a5c70a354SPL ID 9cfe5fe7-abc7-4f48-a597-1b1a5c70a354SPL set ID 9cfe5fe7-abc7-4f48-a597-1b1a5c70a354RxCUI 197557, 197558UNII 8W5C518302UPC 0382804989300, 0382804988303
- Pharmacologic class
- Sulfone
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N482804098900followed by a unit qualifier and the quantityPackage 82804-0989-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Dermatitis herpetiformis: (D.H.) Leprosy: All forms of leprosy except for cases of proven Dapsone resistance.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 086842
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Dapsone | Dapsone 100 mg/1 | TabletOral | Westminster Pharmaceuticals, LLC | 69367-379 |
| Dapsone | Dapsone 100 mg/1 | TabletOral | Westminster Pharmaceuticals, LLC | 69367-410 |
| Dapsone 100 mgdapsone tablets | Dapsone 100 mg/1 | TabletOral | Everest Life Sciences. LLC | 83098-101 |